Title:  Senior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - Hybrid

Job Summary: 

Sun is seeking a Senior Director, Regulatory Advertising and Promotion within its Medical Affairs in Princeton, NJ.  This role will report into Head of Medical Affairs.

The Senior Director, Regulatory Advertising and Promotion requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met. Will ensure materials are consistent with Sun Pharmaceuticals policies and procedures, while enabling the business to compliantly meet its goals and objectives. Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.

Responsibilities:

• Provide regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
• Provide solution oriented and innovative advice to meet the Company's objectives and goals
• Provide strategic advice for the development of Promotion advisory submissions
• Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidance
• Continuously monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice
• Pursues and understands diverse perspectives inside and outside Sun Pharma to provide risk assessment and mitigation strategies
• Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Legal and Compliance
• Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
• Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
• Provide input on process improvement as needed
• Engages with colleagues within the department to help support them in their roles and development
• Provide direct management to individuals depending on assignment
• Proactively seeks opportunities to learn and develop leadership skills

Education & Qualifications:

• Education Required: Advanced degree (MS, PhD, PharmD, or JD)
• Minimum of 5-10 years Regulatory promotional review or 8 to 10 years of related pharmaceutical experience (e.g., Medical promotional review)
• Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
• Strong understanding of FDA regulations (OPDP/CBER).
• Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
• Proven aptitude to analyze and interpret efficacy and safety data
• Represents Ad/Promo at labeling meetings and provides strategic regulatory guidance
• Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
• Excellent verbal, communication, and presentation skills

• Manage, oversee, and review the work of one or more direct reports
• Mentors Ad/Promo and cross-functional team members as needed

The presently-anticipated base compensation pay range for this position is $188,500 to $230,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.